Responders to Metronome-based Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Stride time variability
研究概览
简要总结
Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor impairments are heterogeneous, yet often result in reduced walking ability characterized by slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an emerging rehabilitation approach that leverages auditory-motor synchronization to retrain neuromotor control of walking. Indeed, walking with RAS can enhance walking rhythmicity, gait quality, and speed. RAS is a potentially valuable tool for walking rehabilitation after stroke; however, despite extensive research evidence on the overall benefits of RAS in people with chronic stroke, the notable variability in the walking characteristics of individual patients is likely to influence the effectiveness of RAS intervention, and thus requires study. Furthermore, beyond stroke-related factors, age-related changes may also affect how well individuals post-stroke respond to RAS. This study aims to recruit 24 individuals post-stroke and 20 older adults to evaluate the effects of stroke- and age-related neuromotor impairment on RAS intervention. Each study participant will complete two six-minute walk tests: one without RAS (baseline) and the other with RAS delivered using a metronome. The investigators hypothesize that post-stroke individuals will, on average, exhibit a positive response to RAS intervention (i.e., walk farther and with greater gait automaticity (i.e., reduced stride time variability), with the degree of response predicted by specific baseline characteristics. Furthermore, the investigators anticipate that these walking enhancements will be accompanied by improvements in gait biomechanics and a reduction in the metabolic cost of walking. The investigators hypothesize that older adults will exhibit similar, but attenuated, effects of RAS.
详细描述
Stroke is among the foremost causes of long-term disability worldwide. Though post-stroke neuromotor impairments are heterogeneous, they often result in reduced walking ability and physical activity, and a slow, asymmetric, and unstable gait. In the chronic phase of stroke, the persistence of walking impairment leads to subsequent declines in walking ability, setting off a cycle of disability and deconditioning, reduced mobility, and increased fall risk. The development and study of interventions that can improve walking ability after stroke has been identified as a top priority among patients, clinicians, and researchers, with the ultimate goal being the enhancement of independence and overall quality of life, and the mitigation of walking-related disability.
Stroke is a disease of aging, and older adults (OA) tend to walk more slowly and with a more variable walking pattern that is energetically more demanding. Similar to stroke survivors, the reduced function and quality of walking in older adults can lead to declines in walking ability, initiating a cycle of disability and deconditioning that increases the risk of injurious falls. Hence, maintaining walking function is crucial for preserving a high quality of life.
Rhythmic Auditory Stimulation (RAS) is a rehabilitation intervention that has shown promise for improving walking in both stroke survivors and older adults. Walking with RAS intervention has been proven to enhance walking function, particularly in terms of walking speed. RAS relies on the innate human capacity to synchronize movements with an external rhythm, such as walking to a regular auditory beat, a process referred to as auditory-motor entrainment. Rhythmic entrainment may stabilize gait patterns and reduce the metabolic cost of walking, as the body naturally selects a walking frequency that maximizes stability and minimizes energy expenditure. Moreover, rhythmic entrainment is thought to reduce the cognitive demand of walking, allowing individuals to allocate their attention to secondary tasks essential for safe community navigation. Despite the evidence supporting its effectiveness in improving walking speed and gait function, the biomechanical changes enabling these improvements are not well understood.
Furthermore, while RAS is an effective intervention, not everyone benefits from it equally. Individuals with stroke present with a wide variety of gait patterns, and the degree of gait impairment may influence the effectiveness of RAS intervention above and beyond any age-related changes. In this study, the investigators aim to identify predictors of the response to RAS intervention. More specifically, they seek to understand the association between baseline walking characteristics and the effect that RAS intervention has on walking ability.
For this analysis, the investigators define responders in three ways: (1) individuals who experience an increase in walking function, (2) individuals who see an improvement in gait quality, or (3) individuals who achieve enhancements in both gait quality and walking function while walking with personalized RAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to communicate with investigators clearly
- •The ability to walk without another individual supporting the person's body weight for at least 6 minutes. Assistive devices, such as a cane, are allowed.
排除标准
- •Inability to communicate (as assessed by a licensed physical therapist)
- •Pain that impairs walking ability (as assessed by a licensed physical therapist)
- •Unexplained dizziness in the last 6 months (self-report)
- •Severe comorbidities that affect walking or may interfere with the ability to participate in the study (musculoskeletal, cardiovascular, pulmonary, and neurological)
- •More than 2 falls in the previous month
- •Stroke-specific Inclusion Criteria:
- •at least 6 months post-stroke
- •Older adults specific Inclusion Criteria:
- •65 to 80 years of age
研究组 & 干预措施
Walking without personalized rhythmic auditory stimulation
Subjects will complete a 6MWT without any auditory cues
干预措施: Active walking (Behavioral)
Walking with personalized rhythmic auditory stimulation
Subjects will complete a 6MWT with personalized rhythmic auditory cues
干预措施: Subject-specific optimized RAS (Other)
Walking with personalized rhythmic auditory stimulation
Subjects will complete a 6MWT with personalized rhythmic auditory cues
干预措施: Active walking (Behavioral)
结局指标
主要结局
Stride time variability
时间窗: [RAS-Baseline]
difference in stride time variability with and without RAS (%) within population
Six Minute Walk test distance
时间窗: [RAS-Baseline]
difference in total distance walked with and without RAS within population. (m)
次要结局
- speed changes over the 6MWT([RAS-Baseline])
- stride length changes over the 6MWT([RAS-Baseline])
- cadence changes over the 6MWT([RAS-Baseline])
- Ground Reaction Forces([RAS-Baseline])
- Metabolic Cost of Transport([RAS-Baseline])
研究者
Lou Awad, PT, DPT, PhD
Associate Professor
Boston University Charles River Campus
